CLVL03TP3

Durapore^® 0.1 µm, 高面积，小柱

pore size 0.1 μm, cartridge nominal length 30 in. (75 cm), Code 0

• 分類程式碼代碼: 23151806

屬性

• 材料: PVDF membrane; polypropylene support; silicone O-ring
• 品質等級: 400
• 法律遵循: meets FDA 21 CFR 177-182 (all component materials)
• 無菌: non-sterile
• 滅菌相容性: autoclavable compatible; steam-in-place compatible
• 產品線: Durapore^®
• 特點: hydrophilic
• 製造商／商標名: Durapore^® II
• 技術: sterile filtration: suitable
• 長度: 30 in.
• 寬度: 2.7 in.
• 柱標稱長度: 30 in. (75 cm)
• 設備尺寸: 30 in.
• 過濾面積: 3.3 m²
• 雜質: <0.5 EU/mL USP bacterial endotoxins (LAL test, sample aqueous extraction)
• 重量法萃取物: ≤30 mg/cartridge
• 基質: Durapore^® High Area
• 孔徑: 0.1 μm pore size
• 代碼: Code 0

描述

一般說明

Device configuration: Cartridge
Cartridge type: Liquid

準備報告

This product was manufactured with a Durapore^®  membrane which meets the criteria for a "non-fiber releasing" filter as defined in 21 CFR 210.3 (b) (6).

分析報告

Bacterial Retention: Samples were quantitatively retentive of a minimum Brevundimonas diminuta challenge concentration of 1 x 10⁷ CFU/cm²  using ASTM^® F838 methodology.

Gravimetric Extractables: The extractables level was ≤ 30 mg per 10-inch cartridge after a 1.5 L flush and 24 hours in water at controlled room temperature. 

其他說明

Directions for Use:

• Organism Retention: Microorganism
• Mode of Action: Filtration (size exclusion)
• Application: BioProcessing
• Intended use: Reduction or removal of microorganism/bioburden
• Instructions for Use: Please refer to Wetting Instructions for Filter Units with Durapore^® Membrane user guide
• Storage Statement: Store in dry location
• Disposal Statement: Dispose of in accordance with applicable federal, state and local regulations

法律資訊

ASTM is a registered trademark of American Society for Testing and Materials

Durapore is a registered trademark of Merck KGaA, Darmstadt, Germany